Breast Cancer FemaleNCT06975085
Understanding and Addressing Rejection of Personalized Breast Cancer Risk Information: Administrative Supplement Study
A study testing Presentation of a personal breast cancer risk estimate in people with Breast Cancer Female, run by University of Colorado, Denver at 1 site in United States.
Trial summary
The Understanding and Addressing Rejection of Personalized Cancer Risk Information study is a longitudinal study conducted to understand the nature of phenomenon of personalized cancer risk rejection in the context of mammography screening. Read more about this study
- Who is it for?
- Ages 39 to 74 years, women only
- Conditions the study is for
- Breast Cancer Female
- What is being tested?
- Presentation of a personal breast cancer risk estimate
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 781 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Apr 2025to 30 Apr 2025
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 39 to 74 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female sex
- Age 39-74 (i.e., people who are eligible for routine breast cancer screening and for whom guidelines recommend an informed, risk-based decision)
- English literacy
- Black or African American race
Who cannot join
- 1. Prior diagnosis of
- breast cancer
- Ductal carcinoma in situ (DCIS)
- Lobular carcinoma in situ (LCIS)
- Known BRCA1/2 gene mutation
- Cowan syndrome
- Li-Fraumeni syndrome
- Having received previous chest radiation for treatment of Hodgkin's lymphoma.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Understanding and Addressing Rejection of Personalized Breast Cancer Risk Information in Women
The Understanding and Addressing Rejection of Personalized Cancer Risk Information study is a longitudinal study conducted to understand the nature of phenomenon of personalized cancer risk rejection in the context of mammography screening.
Read the detailed description
The Understanding and Addressing Rejection of Personalized Cancer Risk Information study seeks to understand the nature of the phenomenon of personalized cancer risk rejection in the context of mammography screening by testing hypotheses about why women reject their risk estimate and the influence of rejection on screening intentions.
The Breast Cancer Risk Assessment Tool (BCRAT) will be used to asses participant's breast cancer risk. This model is designed to estimate breast cancer risk in women 35-84, and uses the following predictors: 1) age, 2) age at first menstrual period, 3) age at first live birth, 4) first-degree relatives with breast cancer, 5) previous breast biopsy with atypical hyperplasia, and 6) race/ethnicity. Participants will be required to complete a survey in which they receive their BCRAT model risk estimate and respond to that risk estimate.
- Conditions
- Breast Cancer Female
- Being tested
- Presentation of a personal breast cancer risk estimate
- Keywords
- breast cancer risk, risk perceptions, screening intentions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Presentation of a personal breast cancer risk estimateBehavioural
Participants answer questions that are used to calculate their personal breast cancer risk using the Gail Model. This risk estimate is presented to participants using written text and an icon array.
| Study group | Role | What they receive |
|---|---|---|
| Breast cancer risk presentation | Other | All participants are presented with their personal breast cancer risk, estimated using the Gail Model Receives: Behavioral: Presentation of a personal breast cancer risk estimate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Rejected the Cancer Risk Estimate
Participants are asked whether they agree or disagree with their Gail Model risk estimate. Risk rejection was defined as disagreement the estimate. An open text box allows them to write the risk number that they believe is accurate for them.
Measured: at baseline survey
Risk-concordant Information Seeking
Participants will be given the opportunity to get more information about breast cancer screening, and will be given response options to receive information for women at lower than average risk, higher than average risk, or women with risk that is "about the same as a typical woman". Concordance is measured by agreement between the participants' actual risk estimate and the option that they choose.
Measured: at baseline survey
Screening Intentions
Screening intentions were measured on a 5-point Likert scale. 1=definitely will not, 2=probably will not, 3=maybe, 4=probably will, 5=definitely will. Higher scores indicate greater intention.
Measured: at baseline survey
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2025
- Study start16 Apr 2025
- Primary completion30 Apr 2025
- Study completion30 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast Cancer FemaleStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 781 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Laura D Scherer, PhD, Principal investigator, University of Colorado, DenverErika Waters, PhD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06975085
- Sponsor's protocol ID
- 23-0345
- Other IDs
- R01CA279953
- Status last verified
- Aug 2026
- First submitted
- 7 May 2025
- Last updated
- 15 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The protocol, code books, and data set associated with this study will be shared on the Open Science Framework after ensuring that it is completely anonymized.